product teams. Applies knowledge of current local and global Regulatory trends to identify future regulatory Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc. Responsible regulatory strategy documents Contribute effectively to Global Development programmes, providing expert advice registrations Ensures effective collaboration across the global, regional and local Regulatory Affairs interface
product teams. Applies knowledge of current local and global Regulatory trends to identify future regulatory Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc. Responsible regulatory strategy documents Contribute effectively to Global Development programmes, providing expert advice registrations Ensures effective collaboration across the global, regional and local Regulatory Affairs interface
post-approval product maintenance activities including CMC variations, package insert safety updates, new indications dossiers/ documents. Obtain relevant information from global RA and resolve queries as they arise to ensure artworks are effectively managed through the company, Global Labelling Business Process. Co-ordinate the operations information for accuracy and completeness in the relevant global databases (ERV). Number of submissions in line all outstanding approvals. Regular follow up with Global RA teams on outstanding responses to MCC recommendations
post-approval product maintenance activities including CMC variations, package insert safety updates, new indications dossiers/ documents. Obtain relevant information from global RA and resolve queries as they arise to ensure artworks are effectively managed through the company, Global Labelling Business Process. Co-ordinate the operations information for accuracy and completeness in the relevant global databases (ERV). Number of submissions in line all outstanding approvals. Regular follow up with Global RA teams on outstanding responses to MCC recommendations
(Negotiable depending on skills and experience) Global Manufacturing concern is seeking the expertise
goals and objectives. Actively participate in key global, regional, and national stakeholders for a Line
goals and objectives. Actively participate in key global, regional, and national stakeholders for a Line